Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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The FDA released the pre-market approvals it issued during November 2016, including original and supplemental PMAs. Read more
Trendlines Medical portfolio company Gordian Surgical said this week it won FDA clearance for its TroClose 1200, along with announcing the closure of a $2.3 million funding round.
The Israel-based company’s TroClose 1200 trocar is designed to enable access to the abdomen during laparoscopic surgery, as well as closing the access through suturing incisions in the abdominal wall. Read more
Sirtex Medical shares closed down more than -37% today after the Australian medical device company lowered its profit outlook for the rest of the year.
Sydney-based Sirtex said it expects earnings before interest, taxes, depreciation and amortization to be down -12% on a constant-currency basis compared with fiscal 2016 for the year ending June 30, 2017. The company pegged the expected shortfall to lower-than-forecast dose sales in the Americas and EMEA regions for its SIR-Sphere microspheres, which are used to treat liver cancer. Read more
The U.S. Justice Dept. and Zimmer Biomet are close to reaching a deal to settle bribery allegations against the orthopedic device giant, according to federal prosecutors.
The DoJ alleged that Biomet and its subsidiaries paid out more than $1.5 million in illegal kickbacks to employees of state-owned health services in Brazil and China. Biomet paid $22 million in March 2012 to settle the case with the Justice Dept. and the U.S. Securities & Exchange Commission, agreeing to a deferred prosecution agreement to guard against further misconduct (Zimmer and Biomet closed their $14 billion merger in June 2015). Read more
The U.S. Senate overwhelmingly passed the 21st Century Cures Act, after the U.S. House voted to enact the healthcare measure last week. The bill will move to President Barack Obama’s desk and he is expected to sign it into law soon.
The sweeping healthcare legislation has a number of provisions that are intended to improve the regulatory process for medical devices, such as the requirement that the FDA establish a Breakthrough Devices program to provide priority review for devices that yield “more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions”. Read more